Status:
COMPLETED
P-glypoprotein Inhibition Effect on the Pharmacokinetics of Two Tacrolimus Formulations: Prolonged and Extended-release
Lead Sponsor:
Rennes University Hospital
Conditions:
Pharmacokinetics
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Tacrolimus is a drug administered orally available with different formulations: immediate release (Prograf®), prolonged-release (Advagraf®) and an extended-release one named LCP-Tacro (Envarsus®), for...
Eligibility Criteria
Inclusion
- adults (\> 18 years)
- Non smokers (for at least 6 months)
- Biological parameters within normal range (blood count, urea, creatinine, AST, ALT, GGT, bilirubine)
- BMI within 18 and 25
- Vaccinated against Covid 19
- Negative urinary and plasma pregnancy test
- Having effective contraception for the duration of the study and for 10 days after the last administration of the study treatment (for women and men of childbearing potential)
- Informed consent
Exclusion
- participation to another study with incompatible procedure regarding the French law on research
- Treatment with a drug drug interaction with tacrolimus
- Cardiac rhythm at rest below 50 bpm
- Cardiac issue detected on electrocardiogram
- Cancer or history of cancer
- Chronic infection or history of chronic infection
- Diabetes or history of diabetes
- Hypertension or history of hypertension
- Pregnancy or lactation
- Deprived of liberty (curatorship, guardianship or incarcerate)
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2023
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04489134
Start Date
February 15 2022
End Date
May 16 2023
Last Update
December 11 2024
Active Locations (1)
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1
CHU de Rennes
Rennes, France, 35055